PENUMA
Report
- Report Number
- 3010606546-2022-00006
- Event Type
- Injury
- Date Received
- August 18, 2022
- Date of Event
- July 14, 2022
- Report Date
- August 18, 2022
- Manufacturer
- INTERNATIONAL MEDICAL DEVIES
- Product Code
- MIB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
·THE INCLUSION OF THE EXTERNAL 1-CM-WIDE POLYESTER MESH IS INCLUDED IN THE INSTRUCTIONS FOR USE. ·THE PATIENT IS REQUIRED TO SIGN A CONSENT FORM THAT STATES THEY UNDERSTAND THAT A SOFT MESH LAYER WILL BE ADDED TO THE DISTAL TIP OF THE IMPLANT DURING THE PROCEDURE, AND THAT THEY UNDERSTAND THE POTENTIAL RISKS, COMPLICATIONS, AND BENEFITS OF THE USE OF THIS SOFT MESH. ·A SERIOUS INJURY REQUIRES A REMOVAL TO PREVENT AN INJURY OR ILLNESS THAT IS LIFE-THREATENING, RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, OR NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. ·RISK OF MIGRATION, EROSION AND PAIN ARE RISKS ASSOCIATED WITH EVERY SURGICAL PROCEDURE INVOLVING PLACEMENT OF A SYNTHETIC IMPLANT MATERIAL FOR COSMETIC PURPOSES. A RETROSPECTIVE REVIEW WAS PERFORMED OF THE CHARTS FOR ALL PATIENTS WHO RECEIVED A CURVILINEAR SILICONE BLOCK FOR THE TREATMENT OF SOFT TISSUE DEFORMITIES OF THE PENIS BEGINNING IN FEBRUARY 2013. FROM THAT DATE, 100 SUCCESSIVE PATIENT CHARTS WERE REVIEWED, COVERING A PERIOD THROUGH JANUARY 2014. IN OTHER WORDS, ALL PATIENTS WHO RECEIVED A CURVILINEAR SILICONE BLOCK FOR THE TREATMENT OF SOFT TISSUE DEFORMITIES OF THE PENIS IN THE CLINIC OF DR. JAMES ELIST UNDER THE PRACTICE OF MEDICINE BETWEEN FEBRUARY 2013 AND JANUARY 2014 WERE INCLUDED IN THIS REVIEW. BY REVIEWING PATIENTS WHOSE DATE OF SURGERY WAS IN FEBRUARY 2013 THROUGH JANUARY 2014, SUFFICIENT TIME ELAPSED FOR A COMPLETE REVIEW OF PATIENT FOLLOW-UP SESSIONS FOR AT LEAST ONE YEAR AFTER THE DATE OF SURGERY. PER THE CLINIC'S SURGICAL PROTOCOL, BEFORE EACH PROCEDURE, PATIENTS ARE REQUIRED TO SIGN AN INFORMED CONSENT DOCUMENT THAT, AMONG OTHER THINGS, STATES THAT THEIR DE-IDENTIFIED DATA MAY BE SHARED WITH GOVERNMENT AGENCIES (E.G., THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)). AFTER EACH SURGICAL PROCEDURE, THE CLINIC COLLECTS FOLLOW-UP DATA ON ALL PATIENTS FOR THREE SUCCESSIVE DAYS FOLLOWING THE PROCEDURE, AND AT TWO WEEKS, ONE MONTH, THREE MONTHS, SIX MONTHS, AND TWELVE MONTHS FOLLOWING EACH PROCEDURE. AT EACH FOLLOW-UP SESSION, THE SURGEON ASKS A SERIES OF QUESTIONS TO DETERMINE IF ANY ADVERSE EVENT(S) HAS OCCURRED, THE RELATED SYMPTOMS OF THE ADVERSE EVENT(S), THE SEVERITY OF THE ADVERSE EVENT(S), AND THE POSSIBLE CAUSE(S) OF THE ADVERSE EVENT(S). ·WITH THIS INFORMATION, THE SURGEON DETERMINES THE APPROPRIATE TREATMENT COURSE FOR EACH ADVERSE EVENT, A PREVENTION COURSE TO AVOID FUTURE ONSET, AND CONDUCTS SUBSEQUENT FOLLOW-UP SESSIONS TO DETERMINE THE EFFECTIVENESS OF THE RECOMMENDED TREATMENT COURSE AND MONITOR FUTURE OCCURRENCE. IN THIS GROUP OF PATIENTS, THERE WERE 3 CASES OF EROSION. THIS ADVERSE EVENT WAS OBSERVED BY THE CLINIC ON AVERAGE 8 MONTHS AFTER THE PATIENT'S PROCEDURE WITH A MINIMUM OF 6MONTHS AND A MAXIMUM OF 10 MONTHS. 1 PATIENT EXPERIENCED STRETCHING/EXTENSION OF THE PENILE SKIN OVER THE PENILE GLANS (APPROXIMATELY 2 TO 3 MM), AND 2 PATIENTS EXPERIENCED PROMINENT WRINKLING AND BULGING OF THE PENILE SKIN OVER THE SHAFT. IN ALL CASES, THE CAUSE OF THE EROSION WAS THE PATIENT'S USE OF EXTERNAL DEVICES FOR THE STRETCHING AND EXPANSION OF THE PENILE SKIN, WHICH WAS DONE BY THE PATIENT HIMSELF AND AGAINST MEDICAL ADVICE, INCLUDING SURGEON INSTRUCTIONS AND PRECAUTIONS. THE TREATMENT WAS A SUBSEQUENT PROCEDURE WHEREBY THE IMPLANT WAS REMOVED AND REPLACED. THE 3 PATIENTS WHOSE IMPLANTS WERE REMOVED AND REPLACED WERE SUBSEQUENTLY OBSERVED USING THE CLINIC'S SURGICAL PROTOCOL FOR NEW IMPLANT PATIENTS (I.E., THE CLINIC COLLECTED FOLLOW-UP DATA ON THE PATIENTS FOR THREE SUCCESSIVE DAYS FOLLOWING THE PROCEDURE, AND AT TWO WEEKS, ONE MONTH, THREE MONTHS, SIX MONTHS, AND TWELVE MONTHS FOLLOWING EACH PROCEDURE). NO SUBSEQUENT ADVERSE EVENTS WERE OBSERVED IN THESE 3 PATIENTS WITH THE EXCEPTION OF MILD PAIN. IMD BELIEVES THAT THE UNIQUE ANATOMY, PHYSIOLOGY AND FUNCTION OF THE PENIS DOES NOT INCREASE THE OVERALL POTENTIAL RISKS COMPARED TO THE PREDICATE DEVICES. CLINICAL EVIDENCE DEMONSTRATES THAT RATES OF PAIN, EROSION, AND MIGRATION ARE COMPARATIVELY LOW AND MIGHT BE FURTHER MITIGATED BY PRE-OPERATIVE EDUCATION. ·A CLINICAL INVESTIGATION WAS IRB-APPROVED IN 2015, CLINICAL INVESTIGATION REPORT: RETROSPECTIVE ANALYSIS OF THE SAFETY AND EFFECTIVENESS OF THE SILICONE BLOCK IN PENILE SURGERY. THE 400 CONSENTED MEN AVERAGED 35.5 YEARS OF AGE WITH A MEAN BMI OF 25.4, JUST SLIGHTLY ABOVE THE NORMAL RANGE, AND WERE ALL CIRCUMCISED. 12/400 PATIENTS (3%) EXPERIENCED SERIOUS ADVERSE DEVICE EFFECTS NECESSITATING DEVICE REMOVAL. THE CAUSES INCLUDED IMPLANT BREAKAGE WITH IMPLANT PERFORATION AND INFECTION (4/400 PATIENTS (1%)); IMPLANT INFECTION (4/400 PATIENTS (1%)); SUTURE DETACHMENT (2/400 PATIENTS (0.5%)); IMPLANT BREAKAGE (1/400 (0.25%)); AND HEMATOMA (1/400(0.25%)). THE SELF-CONFIDENCE OPTIONS RANGED FROM 1 (LOW) TO 4 (VERY HIGH). POST-SURGERY, 83.5% OF RESPONDENTS (334/400) REPORTED AT LEAST A 2 CATEGORY IMPROVEMENT IN SELF-CONFIDENCE, AND LONG-TERM, 72.6% (223/307) REPORTED AT LEAST A 2 CATEGORY IMPROVEMENT IN SELF-CONFIDENCE (P <0.001 FOR BOTH). EIGHT-ONE PERCENT (81.0%) OF THE SUBJECTS REPORTED HIGH OR VERY HIGH LEVELS OF LONG-TERM SATISFACTION. RETROSPECTIVE ANALYSIS OF 400 SUBJECTS ELECTING SURGICAL CORRECTION OF PENILE DEFORMITIES DEMONSTRATED THE SAFETY AND EFFECTIVENESS OF SILICONE BLOCK. DEVICE REMOVALS ATTRIBUTED TO AN ADVERSE EVENT WERE RARE, AND SUBJECTS REPORTED IMPROVED SELF-CONFIDENCE AND HIGH LEVELS OF LONG-TERM SATISFACTION. THIS STUDY DEMONSTRATED THE SAFETY OF THE SILICONE BLOCK FOR ITS INTENDED USE. ·COMPLAINT TRENDING AND RISK EVALUATION: 8 OF 12 COMPLAINTS RECEIVED IN 2022 AS OF 08/18/2022 BY IMD FOR THE PENUMA DEVICE FAMILY INVOLVING EXPLANTS DUE TO EROSION. 3 OF THESE COMPLAINTS WERE DETERMINED TO BE NON-REPORTABLE DUE TO PHYSICIAN PROVIDED INFORMATION REGARDING THE LACK OF A SERIOUS INJURY OR ADDITIONAL MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY. 822 PENUMA DEVICES HAVE BEEN DISTRIBUTED BETWEEN SEPTEMBER 2021 AND JUL OF 2022. 5 MDRS HAVE BEEN FILED AS A RESULT OF COMPLAINT INFORMATION RECEIVED BY IMD FROM PHYSICIANS AND MEDWATCH MONITORING. ·THE CURRENT RATE OF EROSION (8 OCCURRENCES FOR 515 DEVICES DISTRIBUTED IN 2022) OF 8/515= 1.55% IS LOWER THAN THE EROSION RATE RECORDED OF 3% IN THE RETROSPECTIVE REVIEW REFERENCED ABOVE. ·THE CURRENT SERIOUS ADVERSE EVENT OCCURRENCE RATE (5 SERIOUS ADVERSE EVENTS FOR 822 DEVICES DISTRIBUTED SINCE SEPTEMBER 2021) OF 5/822=0.61% IS LOWER THAN THE SERIOUS ADVERSE EVENT RATE OF 3% RECORDED IN THE CLINICAL INVESTIGATION REFERENCED ABOVE. ·THE RATE OF OCCURRENCE FOR BOTH EROSION AND SERIOUS ADVERSE EVENTS IS STILL WITHIN LEVELS IDENTIFIED AS A PART OF THE RISK-BENEFIT ANALYSIS FOR THE PENUMA DEVICE. RE-EVALUATION OF THE RISK IS NOT REQUIRED AT THIS TIME. SEROMA INVESTIGATION: ·SEROMAS ARE A POTENTIAL ADVERSE SIDE-EFFECT IN SURGICAL IMPLANTATION OPERATIONS AND ARE IDENTIFIED IN THE DEVICE'S RISK ANALYSIS. ·SEROMAS IN THEMSELVES ARE NOT CONSIDERED TO BE A SERIOUS INJURY PER FDA DEFINITION. ·THE PATIENT ALLEGES THE SEROMA CAUSED THE EROSION. ·AS SEROMAS ARE NOT CONSIDERED A SERIOUS ADVERSE EVENT AND DO NOT WARRANT EXPLANTATION ON THEIR OWN, THE RATE OF OCCURRENCE WAS NOT RECORDED IN THE CLINICAL EVALUATION WHICH MEASURED SERIOUS ADVERSE EVENT OCCURRENCE RATES, SO A TREND COMPARISON IN THE SAME MANNER AS PERFORMED FOR THE INFECTION INVESTIGATION AND EROSION INVESTIGATION IS NOT POSSIBLE. ·3 OF 12 COMPLAINTS RECEIVED FOR 2022 ALLEGE SEROMAS. THE CURRENT RATE OF SEROMA (3 OCCURRENCES FOR 515 DEVICES DISTRIBUTED IN 2022) IS OF A SIMILAR RATE TO THE INFECTION AND EROSION RATE OF OCCURRENCES. ADDITIONALLY, SEROMAS REPRESENT A LOWER LEVEL OF SEVERITY, THEREFORE A HIGHER LEVEL OF OCCURRENCE THAN INFECTION OR EROSION WOULD BE ACCEPTABLE IN ACCORDANCE WITH THE RISK MANAGEMENT PROCESS. SERIOUS INFECTION INVESTIGATION: ·3 OF 12 COMPLAINTS RECEIVED FOR 2022 ALLEGE SERIOUS INFECTION. THE CLINICAL INVESTIGATION REFERENCED ABOVE NOTED A MEASURED OCCURRENCE RATE OF 4/400 = 1%. ·THE CURRENT RATE OF SERIOUS INFECTION (3 OCCURRENCES FOR 515 DEVICES DISTRIBUTED IN 2022) IS 3/515= 0.58%, LOWER THAN THE LEVEL OBSERVED IN THE CLINICAL INVESTIGATION. ·THE RATE OF OCCURRENCE FOR BOTH INFECTIONS AND SERIOUS ADVERSE EVENTS IS STILL WITHIN LEVELS IDENTIFIED AS A PART OF THE RISK-BENEFIT ANALYSIS FOR THE PENUMA DEVICE. RE-EVALUATION OF THE RISK IS NOT REQUIRED AT THIS TIME. ·THE PHYSICIAN DID NOT NOTE ANY INFECTION OCCURRING IN THIS PATIENT IN THE PHYSICIAN PROVIDED REPORT. LABELING INVESTIGATION: ·PENUMA IS A CLASS 2 DEVICE MARKETED UNDER 510(K) FDA CLEARANCE. ANY LABELING AND MARKETING MATERIALS FOR THE PENUMA DEVICE USES THE TERM "FDA-CLEARED", NOT "FDA-APPROVED".
COMPLAINT WAS SENT VIA EMAIL BY THE PHYSICIAN. THE PHYSICIAN STATED THAT THE PATIENT'S PENUMA, IMPLANTED IN (B)(6) 2021, WAS EXPLANTED ON (B)(6) 2022 DUE TO EROSION THAT WAS CAUSED BY A SEROMA. A MEDWATCH REPORT WAS DISCOVERED REGARDING A PENUMA DEVICE DURING ROUTINE MONITORING OF THE MEDWATCH SYSTEM. SEE ATTACHMENT "MW5111052.PDF". THIS REPORT WAS DETERMINED TO BE THE SAME EVENT COMMUNICATED TO IMD BY THE PHYSICIAN FOR THIS EVENT BASED ON THE FOLLOWING: THE MEDWATCH REPORT AND THE PHYSICIAN PROVIDED ADVERSE EVENT FORM BOTH LIST IMPLANT DATES OF (B)(6) 2021 AND EXPLANT DATES OF (B)(6) 2022, IN ADDITION TO BOTH REPORTS DESCRIBING TWO ATTEMPTS TO REPAIR THE IMPLANT PRIOR TO ITS REMOVAL. IN ADDITION TO SEROMA, THE PATIENT ALLEGES THE IMPLANT PUSHED THROUGH A HOLE IN THE PENIS (PATIENT NOTES THE HOLE WAS CAUSED BY PRESSURE BURSTING THROUGH ONE OF THE INITIAL SURGERY WOUNDS), BREACHING THE SKIN AND REQUIRING ANTIBIOTICS FOR SEVEN MONTHS AND ONE WEEK TO MANAGE THE INFECTION. EVENTUALLY THE PATIENT ALLEGES "THE HOLE BECAME TOO LARGE TO EFFECTIVELY MANAGE FOR INFECTION AND I HAD TO HAVE THE IMPLANT REMOVED". THE PATIENT ALSO ALLEGES THE PENUMA IMPLANT IS ADVERTISED AS FDA APPROVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2790528 | PENUMA | PRE-FORMED PENILE SILICONE BLOCK | MIB | INTERNATIONAL MEDICAL DEVIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Required Intervention |